Make a re-check if your CE and classes of your products conform to the new regulations EU.

Pre –Check- List of  Medical Devices  for CE- Europe- 2017

Make a re-check if your CE and classes of your products conform to the new regulations EU.

The classification of medical devices in the European Union is defined according to Directives –the general directive is  93/42/EEC.  There are 4 classes, ranging from low risk to high risk.  

• Class I - non sterile & I sterile & I measurement
• Class IIa- Medium risk
• Class IIb- High Risk
• Class III- High Risk

The classes are indicated in the DOC- Declaration of Conformity of the specific MD.The European classification depends on rules that involve the medical device's duration of body contact, its invasive character, and its Indication For Use .

Class I sterile ,Im ,IIa, IIB ,III should have CE mark

New regulations in Europe – there will be some changes for some class I existing products , acc. To the new regulations , their classes will be changed .

Process to CE

Determine to which directive you belong??

Class of product??

Implement Quality Management System

Prepare a Technical File

Technical file should include:

Ec declaration of Conformity

Product Description

Product specs: like Design, standards etc. DHR

Testing Data

Clinical Studies- literature – results – according to the classification of the product

Essential Requirements form

Labeling

Packaging

Shelf Life

PMS & Vigilance procedure

Certificates

Notification of changes

All Rights Reserved 2017

Best Regards,

Liat Nadel-MA Jurist-RA Expert

L.S.Marketing& Registration-MD Field  www.ls-amarandmore.com